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New Information From FDA On Alleged Problems With Ketek Safety Study 3014
October 2007 FDA Letter Says Aventis Did Not Follow Regulations And Statutory Requirements; Company Contends Study Conducted In Good Faith (Posted by Tom Lamb at DrugInjuryWatch.com) On October 24, 2007 the FDA posted on…
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Is This What Medtronic’s March 21, 2007 “Dear Doctor” Letter Said About Sprint Fidelis Lead Problems?
One Person Took The Impression That Medtronic Was Trying To Lay Blame For Lead Wire Failures On Those Physicians Who Were Doing The Defibrillator Implants (Posted by Tom Lamb at DrugInjuryWatch.com) To start, our…
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Cephalon Added Warning To Provigil Label About Serious Skin Reactions In August 2007
A "Dear Doctor" Letter About Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated With Provigil Was Sent In September 2007 (Posted by Tom Lamb at DrugInjuryWatch.com) On October 24, 2007 the FDA sent an email…
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Congressman Waxman Sends A Letter To FDA Requesting Medtronic Sprint Fidelis Information
Committee on Oversight and Government Reform Wants To Know What The FDA Knew About Defibrillator Lead Wire Fractures And When They Knew It (Posted by Tom Lamb at DrugInjuryWatch.com) On October 22, 2007, as…
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Children And Young Adults Apparently Have A Higher Risk Of Their Sprint Fidelis Heart Wire Fracturing
This Medtronic Defibrillator Lead Line Was Particularly Popular In Younger Patients Due To Its Smaller Size (Posted by Tom Lamb at DrugInjuryWatch.com) In an October 19, 2007 article, "Heart Wires May Pose More Risk…
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FDA Alerts Doctors About Diabetes Drug Byetta And Acute Pancreatitis Reports
Package Insert Will Be Changed To Include Stronger Warning About This Potentially Fatal Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) On October 16, 2007 the FDA issued an alert to doctors informing them…
